FDA.reportPublic FDA data

Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Men

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:51:07

Label at a glance#

ProductHead and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Men
Active ingredientMINOXIDIL
Label structure11 sections

Dosage and administration

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Storage and handling

see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep the carton. It contains important information. hair regrowth has not been shown to last longer than 48 weeks in large clincial trials with continuous treatment with minoxidil topical solution 5% for men in clincial studies with mostly white men aged 18-49 years with moderate degrees of hair loss, mino...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for men

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from fire or flame

OTC - DO NOT USE SECTION

Do not use if

  • you are a woman
  • your amount of hair loss is different than that shown on side of this carton, or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • you do not know the reason for your hair loss
  • you are under 18 years of age. Do not use on babies and children
  • your scalp is red, inflamed, infected, irritated or painful
  • you use other medicines on the scalp

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have heart disease

OTC - WHEN USING SECTION

When using this product

  • do not apply on other parts of the body
  • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
  • some people have experienced changes in hair color and/or texture
  • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for all men.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • sudden, unexplained weight gain occurs
  • your hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 4 months

OTC - PREGNANCY OR BREAST FEEDING SECTION

May be harmful if used when pregnant or breast-feeding

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
  • using more or more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other information

STORAGE AND HANDLING SECTION

  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed leaflet
  • keep the carton. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clincial trials with continuous treatment with minoxidil topical solution 5% for men
  • in clincial studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men proided more hair regrowth than minoxidil topical solution 2%
  • store at 20-25° C (68-77° F). Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol,propylene glycol, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202.

PRINCIPAL DISPLAY PANEL - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Head & Shoulders

SCALP X

MINOXIDIL

TOPICAL SOLUTION USP, 5%

HAIR REGROWTH

TREATMENT

FOR MEN

Extra Strength Topical Solution

CLINICALLY PROVEN TO HELP REGROW HAIR

Reactivates Hair Follicles to Stimulate Regrowth

Three month supply

Unscented

3 - 60 mL (2 FL OZ) BOTTLES

TOTAL 180 mL (6 FL OZ)

HSHS

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-55969423-559-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINOXIDIL5965120SH1ACTIB
DEHYDRATED ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4744d648-5469-220c-e063-6294a90a3d6cf28f6336-1c3d-769b-e053-2a95a90a3deb2025-12-31WarningsExact identifier
spl id: 4744d648-5469-220c-e063-6294a90a3d6c
spl set id: f28f6336-1c3d-769b-e053-2a95a90a3deb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.